S1316 – The Malignant Bowel Obstruction Study A Prospective Comparative Effectiveness Trial...

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Transcript of S1316 – The Malignant Bowel Obstruction Study A Prospective Comparative Effectiveness Trial...

A Supportive Care Vision for Arizona

S1316 The Malignant Bowel Obstruction StudyA Prospective Comparative Effectiveness Trial for Malignant Bowel ObstructionSWOG Study Chairs:Robert S. Krouse, M.D., SAVAHCS/University of Arizona, Surgical OncologyBrian Badgwell, M.D., MD Anderson Cancer Center

Alliance Investigator:Amy Abernethy, M.D., Duke University Medical Center

Nurse Chair:Virginia Sun, R.N., Ph.D., City of HopeS1316 - MBO Professional Slide Set, Version 01Other Key Staff on S1316 are:Biostatisticians: Garnet Anderson, Ph.D., and Katie Arnold, M.S., SWOG Statistical Center, Fred Hutchinson Cancer Research Center

Arizona Diet, Behavior and Quality of Life Assessment LabCynthia A. Thomson, Ph.D., R.D.Canyon Ranch Center for Prevention & Health Promotion

1S1316JACS Paper on MBOAggressive non-surgical palliative care options can help avoid an operation There are many clinical scenarios when an operation is unlikely to benefit MBO patients Can we test which treatment strategy (surgery vs. aggressive palliative management) is optimal in MBO?S1316 - MBO Professional Slide Set, Version 012S1316- MBO Study AimsTo assess the quality of life outcome of the number of days alive and outside of the hospital within the first 91 days (13 weeks) after registration, for patients with malignant bowel obstruction who receive surgical intervention as compared to non-surgical intervention.

Research Questions:Are there differences in HRQOL outcomes for patients with MBO who receive surgical intervention as compared to non-surgical intervention?Are there clinical factors that predict better HRQOL outcomes for patients with MBO who receive surgical or non-surgical intervention?S1316 - MBO Professional Slide Set, Version 013S1316 MBO StudyPrimary EndpointGood days = days out of the hospital and alive in the first 91 days (13 weeks) after registration Secondary EndpointsDays with NG tubeDays eating (Diet recalls)HRQOL (MDASI-GI, EQ-5D-5L) Morbidity/MortalitySurvival

S1316 - MBO Professional Slide Set, Version 01The endpoints chosen were based on the extensive literature and clinical experience with MBO patients. The primary endpoint is Days out of the hospital and alive. There is ample evidence that the primary goal for patients with end stage disease is to be at home/out of the hospital. While it is imperative to collect other quality of life data, this is the optimal objective outcome for this population. Over 90% of hospice care is at home; therefore, days out of the hospital means days out of the acute care setting. While this is typically at home, it can also be at an inpatient hospice facility.

4S1316 - MBO Professional Slide Set, Version 01S1316 Study Timeline201420152016Study accrues20172018Study closes to accrualPrepare for study activationTrainingObtain IRB approvals2019Study data complete and submittedComplete data clean-upAnalyze data for primary endpointPrepare abstractWrite and publish primary paperWork on secondary analyses2020S1316 - MBO Study SchemaS1316 - MBO Professional Slide Set, Version 01Meets all eligibility requirements (N=180)Consents to randomization (N=50)Consents to non-randomized treatment(N=130)Surgery (50%) (Arm 1)Non-surgical management (50%) (Arm 2)Surgery (Arm 3)Non-surgical management (Arm 4)All patients will be followed for 53 weeks.Arms 1 and 3: Surgery Patients on surgical management will undergo abdominal surgery as defined by the treating physician. Surgery is defined as an operative procedure. Information regarding patient treatment will be collected. While randomization to Arm 1 will determine a patients initial care, the treating physician will take changes in their clinical course or other circumstances into account in determining the ongoing care plan.

Arms 2 and 4: Non-surgical Management Patients on non-surgical management will be offered non-surgical management as determined by the treating physician. Information regarding patient treatment will be collected.

While the research team believes there is sufficient equipoise to randomize to such a trial, it is likely infeasible to accrue the entire population to a RCT at this time. Therefore, this study proposes to accrue a large number (n=180) and randomize a subset of these (n=50) accruing at selected institutions demonstrating substantial interest in and commitment to this question. This combined approach builds on the strengths of each design to give more reliable results. While the RCT component of this hybrid design could be considered a pilot trial, by embedding this trial in a larger non-randomized component, we believe we will have stronger inference than could be achieved by either alone.

6S1316 - MBO Professional Slide Set, Version 01S1316 Patient TimelineHospitalization with MBOWeek 53Follow-up CompleteDay 0Registration

Week 13Data for primary endpoint reportedSite calls patient every 4 weeks for assessmentsPatient has dietary recall every 4 weeksReport all hospitalizationsSite calls patient weekly for assessmentsPatient has dietary recall every 4 weeksS1316 - MBO StudyAccrual GoalStudy will accrue 180 eligible patientsStudy expects to accrue over 3 yearsTwo study componentsRandomization component (n=50)Non-randomized component (n=130)

S1316 - MBO Professional Slide Set, Version 01While the research team believes there is sufficient equipoise to randomize to such a trial, it is likely infeasible to accrue the entire population to a RCT at this time. Therefore, this study proposes to accrue a large number (n=180) and randomize a subset of these (n=50) accruing at selected institutions demonstrating substantial interest in and commitment to this question. This combined approach builds on the strengths of each design to give more reliable results. While the RCT component of this hybrid design could be considered a pilot trial, by embedding this trial in a larger non-randomized component, we believe we will have stronger inference than could be achieved by either alone.8S1316 MBO StudyEligibility CriteriaMBO due to intra-abdominal cancerAdmission to hospitalSurgical candidate (would tolerate an operation and indication for surgery) Performance status (Zubrod Performance Status of 0 - 2 one week prior to admission)Able to complete questionnaires in English

S1316 - MBO Professional Slide Set, Version 01Required studies: H & P, CT or MRI for disease assessment, and serum albumin will be collected after admission but prior to treatment.

Optional studies: CBC and electrolyte panel will be collected after admission but prior to treatment. 9S1316 MBO StudyIneligibility Criteria (contd)MBO not due to intra-abdominal cancerPatient actively dyingPatient requires an emergency surgical procedure, e.g., acute abdomenPatient refuses to allow study staff to contact him/her for study follow-up

S1316 - MBO Professional Slide Set, Version 0110S1316 MBO StudyTimeline for Initial Patient CareS1316 - MBO Professional Slide Set, Version 01Time from initial surgical consult to start of treatment should not be more than a week.Treatment may begin on the same day as the surgical consult as long as the order of events is preserved (surgical consult first, then registration, then treatment).Treatment must begin after registration. Patients for whom treatment is initiated prior to registration are ineligible.Up to 3 working daysUp to 2 working days|----------------------------|---------------------------|Surgical Consult or admission to Surgical ServiceRegister to S1316Begin Treatment11S1316 MBO StudyInitial Data SubmissionBaseline dataOnstudy, MDASI-GI, EQ-5D-5LMBO treatment and complications data for initial hospitalizationPathology report to confirm primary cancerRadiology reports to confirm MBO

S1316 - MBO Professional Slide Set, Version 01S1316 MBO StudyFollow-UpWeekly phone assessments and data collection by study site staff for first 13 weeks and every 4 weeks thereafter up to one yearDietary recall phone calls every 4 weeks up to one yearMBO treatment and complications data for all hospitalizations in first 13 weeksS1316 - MBO Professional Slide Set, Version 01All patient-completed study forms will be administered via telephone or in person, if patient is in the hospital and allows an in-person visit. Follow-up assessments of patients are based from the date of registration. The time window for each phone assessment is +/- 2 days to allow for scheduling. If a follow-up call or visit is missed, the information that was missed will be included during the next completed call or visit.

Every effort should be made to collect the follow-up data in identical fashion across all study arms (surgical vs. non-surgical management, randomized vs. non-randomized).

13S1316 MBO StudyDietary Recall Self-reported diet measurement methodsRelies on patient or caregiver to report foods consumed in prior 24-hour periodCollected by Arizona Diet, Behavior, Quality of Life Assessment Lab through phone contactS1316 - MBO Professional Slide Set, Version 01S1316 MBO StudyCriteria for Removal from Protocol Follow-upCompletion of 53 weeks on studyMedical condition that the treating investigator believes precludes continued participationPatient refusal for any reason, including discontinuation of weekly phone callsAll reasons for discontinuation of follow-up will be documented but hospitalization data and vital status will still be reported.S1316 - MBO Professional Slide Set, Version 01If a patient no longer wants to complete the study phone calls, if appropriate, the site should ask if the follow-up calls can be made solely to the patients designated representative before removing a patient from follow-up.15S1316 MBO Study Analysis PlanStudy includes two components: randomized (n=50) and non-randomized (n=130)Inference will be based on assigned treatmentRandomized component will use randomized tre